Tag: drug regulation
Ecstasy Nears FDA Approval to Treat Severe Post-Traumatic Stress Disorder
In a heart-wrenching story written in 2017, Rachael Kaplan details her lifelong struggles with Post Traumatic Stress Disorder (PTSD). Enduring chronic and severe abuse as a child, Rachael strongly considered ending her life and found herself “praying to die.” She worked with several therapists and numerous multiple treatment methods to improve her condition. Unfortunately,...
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To Make Drugs More Affordable, President Trump Should Focus on Price Competition
President Trump has tried seemingly everything to lower prescription drug prices. In 2018 alone, he established an international pricing index to prevent overcharging from foreign drug producers, targeted drug rebates between producers and middlemen, and granted Medicare Part D plans more authority to negotiate drug prices. Despite these and other efforts, the prices for thousands of...
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Cut Regulations and Get COVID-19 Drugs to Patients
As the coronavirus pandemic continues to ravage the U.S. healthcare system, many healthcare professionals are struggling to find enough medical supplies to treat patients and to avoid becoming infected themselves. A recent New York Post article finds nurses working in a New York City hospital resorted to covering themselves with garbage bags because the...
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FDA’s Approval of Generic Daraprim Offers Lessons on Drugs Prices
In 2015, Turning Pharmaceuticals CEO Martin Shkreli increased the price of the drug Daraprim nearly 5,000 percent from $13.50 to $750 per pill. The price hike generated widespread outrage, earning Shkreli the moniker “Pharma Boy” and the designation, “pharmaceutical greed villain.” Daraprim became “the poster child for the issue of high drug prices.”
Politicians Still Misunderstand High Insulin Prices
In 2015, the Centers for Disease Control ranked diabetes seventh among the leading causes of death in the United States. If current trends continue, skyrocketing death rates and other serious consequences of poorly managed diabetes will continue. Managing diabetes is challenging, often requiring strict dieting, regular exercise, and taking a variety of medications. For...
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Robert Klein, Davy Crockett, and the Quest for Another $5.5 Billion for Stem Cells
As this column has often noted, the 2004 ballot measure Proposition 71, the $3 billion California Stem Cell Research and Cures Act, promised life-saving cures for Alzheimer’s, Parkinson’s and other diseases, plus a steady stream of royalties for state coffers. In 2020, a ballpark estimate for the promised cures and therapies is zero, and...
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Will FDA Approve Biogen’s Promising New Treatment for Alzheimer’s?
We’re only a few weeks into the new year, and the Food and Drug Administration will soon make a decision that will affect pharmaceutical regulation for decades. Last year, after failing an FDA-required futility test, Biogen abandoned its efforts to develop an Alzheimer’s treatment named aducanumab. However, after conducting an analysis using an expanded...
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Breakthrough Alzheimer’s Drug Puts FDA’s Drug-Approval Process into Question
After many successful years as a corporate manager, Roger retired in his late sixties to spend more time with family. Three years into retirement, his once energetic and outgoing demeanor deteriorated, and he no longer found interest in things he once enjoyed. Concerned, his physician referred him to a psychiatrist. During his evaluation, Roger...
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Misdiagnosing Right-to-try Laws
Right-to-try laws only apply to terminally ill patients who have exhausted all other options.
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